510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171519FLXfit™Expanding Orthopedics, Inc.2017711
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+4K143143Pathway ElifCustom Spine, Inc.201514—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K133192Mectalif TipeekMedacta International201416—
+4K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K123969XiphosDifusion Technologies201314—
+4K123388K7C SpacerK7, LLC20130—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+4K121581Box Peek VBR System,Innovasis, Inc.20121—
+4K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K113478Plif CageEisertech, LLC2012269—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K112493Pass LP Spinal SystemMedicrea International20111—
+4K111965Vusion (R) OSOrtho Development20110—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—